- Device
- HeartStart FR3 Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160028
- Supplement
- S004
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-06-15
- Decision code
- APPR
- Date received
- 2021-05-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updating the safety alert from a Caution to a Warning in the instructions for use for the FRx and FR3 Infant/Child Keys.